Computer Systems Validation for the Pharmaceutical and Medical Device Industries
- ISBN-10
- 0963148907
- ISBN-13
- 9780963148902
- Category
- Medical instruments and apparatus
- Language
- English
- Published
- 1994
- Author
- Richard Chamberlain
Description
This book presents the topic of computer systems validation in a regulated environment in a manner that the layman can understand. It explains the relationship of validation to the implementation of computer systems. A step-by-step plan for implementing validation procedures in almost any environment is given. The chapters cover preparing validation protocols, writing & implementing Standard Operating Procedures, testing systems, managing files, preparing documentation, conducting audits & inspections, & operating in a validated environment. One of the appendices to the book includes 16 draft Standard Operating Procedures. The book comes with two floppy disks (3.5 & 5.25 inch) each containing the draft Standard Operating Procedures & the forms introduced in the book in both ASCII & WordPerfect formats. The book is essential for management, quality assurance, scientists, & information management personnel in both of these industries.
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